Neuroscience Clinical Trials

With significant unmet medical needs in the treatment of Alzheimer’s disease and other cognitive disorders, stroke, multiple sclerosis, epilepsy, Parkinson’s disease, and other disorders, the demand for innovative central nervous system (CNS) therapies is expected to grow. If you are currently planning a clinical program in this area, PharmaNet’s neuroscience medical and operational staff is exceptionally well-versed in the conduct of neuroscience trials with experience spanning virtually all CNS indications and drug delivery methods, and with staff strategically placed throughout the world.

PharmaNet has successfully conducted more than 100 neuroscience trials over the past five years. For every project, senior level CNS experts are aligned with project teams led by seasoned neuroscience project managers and staffed by monitors with neuroscience experience. This extraordinary level of expertise:

• Drives operational efficiencies across neuroscience projects;
• Builds and strengthens positive relationships with key opinion leaders (KOLs), regulators , and psychiatry and neurology sites that meet enrollment goals and provide high quality data;
• Provides clients with engaged, accessible and therapeutically informed senior management.

Our expertise includes neuroscience research in pediatric and adolescent populations, with experience in a range of conditions affecting children: epilepsy, schizophrenia, depression, ADHD, and surgical pain (neonates and pediatrics).

PharmaNet has also worked on rare disease trials, working effectively with the dynamics of clinician, family and caregiver involvement in the well-networked research and patient advocacy environment associated with devastating and debilitating disorders such as Duchenne muscular dystrophy (DMD), Fabry’s Disease, Gaucher’s, and metachromatic leukodystrophy (MLD).

We are familiar with the spectrum of delivery methods in research with small molecules and biologics, including oral administration of immediate and controlled release formulations, transdermal delivery systems, injection, IV infusion, intranasal, inhalation and intrathecal delivery devices. We have also worked with gene therapies, including trials involving surgical procedures to administer treatment.

PharmaNet will select and align key partners as needed for you study, working collaboratively with highly experienced neurologists, psychiatrists, pain specialists and providers of assessments tools and biomarkers. PharmaNet has successfully supported trials employing customized assessment batteries, expert rater training, and a range of biomarkers for diagnostic purposes and as primary, secondary and exploratory endpoints in neuroscience.

NEUROLOGY AND NEURODEGENERATIVE DISEASE

PharmaNet has performed approximately 30 studies in neurodegenerative disorders. We have acquired specialized expertise by conducting more than 20 trials in Parkinson’s Disease and established relationships with over 165 movement disorder clinics worldwide. Our neurology experience includes:

• Alzheimer’s disease
• Autism
• Epilepsy
• Multiple sclerosis
• Muscular dystrophy
• Parkinson’s disease
• Sleep disorders
• Stroke
• Vestibular neuritis

PSYCHIATRY AND BEHAVIORAL DISORDERS

PharmaNet has long-standing relationships with research sites that have access to patient populations with schizophrenia, expertise in psychiatric ratings, experienced staff, high ethical standards and predictable enrollment.

We have worked on eight schizophrenia programs in 17 countries, at ~200 sites, including ~2000 patients. As evidence of our strong work this area, one sponsor has been working with us for over six years; trusting PharmaNet for both pediatric and adult schizophrenia programs for several drugs. Our experience in psychiatry includes:

• ADHD
• Alcoholism/Addiction
• Anorexia nervosa
• Anxiety
• Bipolar disorder
• Depression
• Schizophrenia
• Smoking cessation

For information on our experience with pain studies, click here.